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Athersys (ATHX) Misses Q3 EPS by 2c

November 9, 2020 5:20 PM EST
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Price: $0.10 --0%

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Athersys (NASDAQ: ATHX) reported Q3 EPS of ($0.11), $0.02 worse than the analyst estimate of ($0.09).

Highlights of the third quarter of 2020 and recent events include:

  • Received Regenerative Medicine Advanced Therapy (RMAT) designation for MultiStem® from the U.S. Food and Drug Administration (FDA) for the treatment of acute respiratory distress syndrome (ARDS), a designation enabling additional interactions with the FDA that are focused on expediting development;
  • Commenced patient screening for the Phase 2 clinical trial led by The University of Texas Health Science Center at Houston (UTHealth) evaluating MultiStem Administration for Trauma Related Inflammation and Complications (MATRICS-1) in patients at Memorial Hermann-Texas Medical Center, a leading Level 1 Trauma center;
  • Further advanced the MACOVIA Phase 2/3 trial evaluating MultiStem administration to patients with COVID-19 induced ARDS and advanced preparations to potentially expand the study to include a broader range of patients with ARDS, including from influenza and other pathogens;
  • Advanced the MASTERS-2 ischemic stroke study, reactivating all clinical sites previously impacted by COVID-19 operational disruptions, and adding new sites to the study;
  • Received notification that HEALIOS K.K. (Healios), our Japanese partner, completed enrollment of its COVID-19 induced ARDS patient cohort in its ONE-BRIDGE study. Healios has previously stated it intends to complete enrollment of the entire ONE-BRIDGE study and the TREASURE ischemic stroke study by around the end of the year;
  • Advanced our partnering negotiations regarding MultiStem for potential commercialization in Europe and other regions of interest;
  • Continued key initiatives for establishing commercialization readiness, including supply chain and logistics, process development, manufacturing, branding and other key areas;
  • Recognized net loss of $22.5 million, or $0.11 net loss per share, for the quarter ended September 30, 2020; and
  • Ended the third quarter with $61.7 million of cash and cash equivalents.

“Despite the continuing chaos created by the ongoing COVID-19 pandemic, we made excellent progress this quarter. Our clinical programs and ongoing partnering negotiations continue to advance, and our efforts to establish commercial readiness in several key areas have also made good progress,” commented Dr. Gil Van Bokkelen, Chairman and CEO of Athersys. “We have maintained a strong financial position while also continuing to build key capabilities that would support our planned transition into commercialization following regulatory approval of our innovative therapies.

“Completing a high value partnership for Europe and potentially other geographies is an important near-term priority, and we are focused on achieving that goal, which will be a key event in the continued evolution of the company,” concluded Dr. Van Bokkelen.

For earnings history and earnings-related data on Athersys (ATHX) click here.



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